ISPE Baseline Guide Vol 2: Oral Solid Dosage Forms (Third Edition)

 

Technical content within this Baseline Guide covers pharmaceutical facilities for the manufacture of OSD forms, including tablets, capsules, and general powders. It may also be applied to pilot and clinical supply facilities and is intended to supplement Good Engineering Practice (GEP) with suggested approaches to Good Manufacturing Practice (GMP).

TRS 1033 - 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations

 

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. Standards are developed by the Expert Committee through worldwide consultation and an international consensus-building process. 

Dược điển Mỹ 43 (USP 43 NF38)

The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics